Combined intracutaneous and intraperitoneal anaesthesia for postoperative pain reduction after laparoscopic cholecystectomy - Intense Trial
- Conditions
- Symptomatic gallstone diseaseMedDRA version: 9.1Level: LLTClassification code 10018109Term: Generalized convulsive epilepsyMedDRA version: 9.1Level: LLTClassification code 10007647Term: Cardiovascular collapseMedDRA version: 9.1Level: LLTClassification code 10002199Term: Anaphylactic shock
- Registration Number
- EUCTR2009-012639-13-NL
- Lead Sponsor
- Meander Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 74
Patients aged 18-75 years with an ASA I or II classification who undergo elective laparoscopic cholecystectomy for symptomatic gallstone disease
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
-Patients with cholecystitis, septic shock from cholangitis, severe acute pancreatitis, advanced cirrhosis, and gallbladder cancer
-Patients with a medical history of epilepsy, cardiac arrhytmias or chronical pain of any kind .
-If a patient is allergic to drugs of the amid type.
-Pregnancy
-Subject suffering from hypotension or hypovolemia.
-Subjects suffering from liver disease
-Subject using drugs which deduce function of the CYP3A4 system like ketoconazol.
-Subject using drugs which deduce function of the CYP1A2 system like the methylxanthines(Fluvoxamin enoxacin)
-Patients with a psychiatric disease or other conditions making them incapable of filling out the questionnaires or completing the objective follow up tests
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method